Mask for the administration of inhaled drugs

Abstract

A breathing mask for use in administering inhalable medications to a patient in need of an inhaled drug is provided. The mask disclosed herein is particularly useful for use with very young children. The mask is made from a flexible molded plastic silicone or elastomeric material, and has an anthropometrically / anatomically / ergonomically contoured shape to provide a good seal, a comfortable fit, and minimal dead space within the mask. The airway is aligned with nose. There may be an orifice for use with a soother device to calm a child using the mask. Also provided is a visual flow indicator to provide an indication of the quality of the seal of the mask on the face.

Description

CROSS REFERENCE TO RELATED APPLICATION[0001]This application claims priority to U.S. provisional patent application No. 61 / 498,384, filed Jun. 17, 2011, the entire contents of which are incorporated herein by reference.FIELD OF THE INVENTION[0002]The present invention relates to a mask for the administration of inhalable drugs, particularly by children and infants.BACKGROUND[0003]A significant problem faced by medical professionals is the need for effective devices for the delivery of drugs to infants and children, in particular inhalable drugs in the form of aerosols, powders, vapors, or mists. Typical examples of such drugs that are widely used are asthma drugs, which employ pressurized metered dose inhalers (MDI) that deliver a measured dose of an aerosolized liquid or powder to a mouthpiece. In some cases, holding chambers are used, that serve to trap larger particles and provide a reservoir for suspended drug aerosol if the chamber is used with an inhalation mask. Other devices...

AI Technical Summary

Problems solved by technology

A significant problem faced by medical professionals is the need for effective devices for the delivery of drugs to infants and children, in particular inhalable drugs in the form of aerosols, powders, vapors, or mists.

Children however lack the coordination, understanding, or communication skills necessary to use conventional drug inhalation devices.

Also, a known problem with infants or children in the administration of inhaled medicaments is that existing masks often cause agitation and distress in a child, and makes them cry.

If this occurs, the child will usually become uncooperative, and the disruption and uneven breathing during crying will probably prevent effective delivery of the drug substance to the lungs.

Another problem with infants and children in the administration of inhaled medicaments is that masks for children have hitherto been essentially shrunken versions of masks used for the administration of oxygen or anesthesia in adults.

They tend to not fit well, tend not to have a good seal, and often fit poorly at the extremes in size, so a plurality of sizes is necessary to ensure a good fit.

Another significant consideration is that children's faces change rapidly in the first few years of life, so a mask that is effective at say, 12 months of age may not provide a good seal at 18 months of age.

As noted elsewhere herein, infants are nasal breathers, so this alignment assures substantial (and undesirable) dead space in the mask.

If there is a large dead space, a substantial amount of the active drug may be suspended in the dead space after an initial inhalation.

The exhalation valve is a one-way valve that allows exhaled air to vent out of the interior of the mask, but does not allow outside air to enter during inhalation.

But, there is little empirical or scientific evidence for the design of pediatric masks for use in children.

The issue of adequate fit is a particular problem in infants and young children whose face undergoes rapid and marked developmental change in the first few years of life.

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